Patenting in Life Sciences

2013-09-19

Common understanding among startup entrepreneurs, policy makers and even inexperienced investors in life sciences and bio pharma business is that the patents shall be filed for as soon as possible. While not entirely untrue, several major reservations about this need to be understood.

First and foremost, patents are extremely expensive and limited in time. Patenting at the early stage of technology development usually erodes value of the technology for the potential partners and investors at the later stage. Early technology is usually unripe for commercialization, hence leaving important parts (which will be developed later) out of the patent. Early patenting consumes limited financial resources and most importantly robs the inventor team of time and attention, which may be better spent on advancing the technology itself, especially early on, when the morale and enthusiasm are at the highest.

Second, early patenting significantly decreases the final product patent protection time. Thus, even if the technology is a success, the inventors will only be able to extract value from the last few years of the patented product on the market, instead of more than a decade or more.

It is essential for everyone involved to understand that development process in life sciences is very long. Five years is a general minimum for pre-clinical development phase, where the technology does not leave the premises of the inventor. As long as reasonable security and confidentiality strategy is adopted, the risks of postponing the patenting in non-crowded technological fields are worth the potential payout from the mature and timely patent. Even in the busy fields, such as oncology, creative provisional patenting approach in different jurisdictions provides possibilities to postpone patenting and maximize benefits.

Patenting decisions in the startup and academic setting shall be based mainly on the risk assessment that the competing team will publish or patent something that would preclude patenting of your technology, but not on the internal urge to patent, the wish to acquire patent bragging rights, or report patents as an achievement or product.

Most of the early patents in any field, and especially in life sciences (due to major investment, effort and time needed to convert the inventive technology into a product), end up as zombie patents – value-less due to lack of inventive step and claim limitations, or abandoned due to lack of resources to support them and to protect them internationally. Such patents are food for patent trolls and a burden to the future inventors and society.

For inventors and entrepreneurs in life sciences it is essential to have patent experience on the team early on and to design the patenting strategy early. Creative provisional patent applications offer a good alternative. A lot of patience is also essential. For policy makers, it is essential to understand the slowness of the development process, and the perils of early patenting in life sciences. The focus on the growth potential, rather than patents at face value, is more important.